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government regulation 2 articles

Meningitis outbreak raises questions about safety of compounding pharmacies

There are about 7,500 pharmacies in the United States that customize medications for patients, doctors and health care facilities. These compounding pharmacies take medicines from pharmaceuticals manufacturers and make them into specific dosages and strengths. They are not regulated by the Food and Drug Administration (FDA), as drug ingredients are. Instead, oversight is left to state agencies. But a deadly outbreak of fungal meningitis traced back to an injectable steroid made at a specialty pharmacy in Massachusetts has raised questions about the safety of products that come from compounding pharmacies. The problem arises when these pharmacies split, repackage or mix ... Read More

Consumers Union fights for more oversight of medical devices

The Consumers Union (CU) is hoping to close a loophole in the approvals of medical devices that allows them to be cleared for marketing in the United States with almost no government regulation, testing or monitoring. According to its mission statement, CU is an expert, independent, nonprofit organization whose mission is to work for a fair, just, and safe marketplace for all consumers and to empower consumers to protect themselves. CU also publishes the magazine Consumer Reports and the website ConsumerReports.org. Currently, medical devices considered moderate-risk, such as transvaginal mesh and artificial hips, are approved through an accelerated process that ... Read More